Olympus Corporation of the Americas: The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140

Hazard

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

Details from the source

Reason for recall: The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure. Distribution: US Nationwide distribution. Quantity: 29590 units Lot/code info: UDI-DI: 04953170355929. All lot numbers

UPC codes

04953170355929

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.